Ovarian Cancer Test Marketed without FDA Approval

FDA Cautions Manufacturer

A serum-based test designed to detect the presence of ovarian cancer has been illegally marketed, according the FDA. The agency has sent a warning letter to Laboratory Corporation, the manufacturers of OvaSure, stating that the company does not have marketing clearance or approval from the FDA for the test.

The crux of the problem is a lack of scientific evidence to show that the test is reliably accurate in detecting the presence of ovarian cancer. An earlier study used to validate OvaSure, published in the February issue of Clinical Cancer Research, showed that the biomarker used in OvaSure correctly identified 221 of 224 samples, providing an accuracy rate of 98.7 percent.

However, the FDA argues that the study was strongly biased, because the study population consisted of women who either already had ovarian cancer, or who were healthy.

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Published on Oct-13-08